Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-04

Study Completion Date

2024-10-28

Brief Summary

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Setting: Translacional Surgery Graduation Program - Universidade Federal de São Paulo and Hospital das Clínicas Samuel Libânio - Universidade do Vale do Sapucaí. Background: Breast reduction is one of the most performed plastic surgery procedures. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. Objective: To compare the influence of the use of prophylatic antibiotics as a single dose or for 24 hours on surgical site infection rates following reduction mammaplasty. Methods: Randomized trial of non-inferiority, with two parallel groups, double blinded. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to group A, that will receive antibiotics only at the anesthesia induction (n=73), or to group B, that will receive antibiotics at the anesthesia induction and for 24 hours (n=73). None of the patients will receive antibiotics after hospital discharge. Patients will be followed-up weekly, for 30 days, regarding surgical site infection. The Centers for Disease Control and Prevention criteria will be applied. A statistical analysis of the data will be performed.

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Detailed Description

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Conditions

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Plastic Surgery Mammaplasty Anti-bacterial Agents Prophylaxis Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Cephazolin

Patients will receive antibiotics (1g cephazolin) intravenously at the anesthestic induction and every 6 hours for 24 hours

Group Type EXPERIMENTAL

Cephazolin

Intervention Type DRUG

Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and postoperatively every 6 hours, for 24 hours.

Sterile saline

Patients will receive antibiotics (cephazolin) only at the anesthesia induction, and sterile saline intravenously every 6 hours for 24 hours

Group Type PLACEBO_COMPARATOR

Sterile saline

Intervention Type OTHER

Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and intravenous sterile saline postoperatively, every 6 hours, for 24 hours.

Interventions

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Cephazolin

Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and postoperatively every 6 hours, for 24 hours.

Intervention Type DRUG

Sterile saline

Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and intravenous sterile saline postoperatively, every 6 hours, for 24 hours.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 and 60 years of age
* body mass index (BMI) between 19 and 30 kg/m2
* breast hypertrophy according to the criteria of Sacchini et al. and Franco and Rebello

Exclusion Criteria

* patients who had previously undergone another surgical procedure of the breast
* patients who have been diagnosed with a breast pathology
* smokers
* patients who had a child or breastfed within the last year
* patients with uncontrolled comorbidities, such as arterial hypertension or diabetes
* use of immunosuppressants
* patients who had any infection during the follow-up period, requiring the use of antibiotics
* patients who present any adverse effects due to the antibiotics during the study
* patients who miss follow-up assessments
* patients who withdraw their consent at any time

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No